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The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

Primary Purpose

Intrauterine Adhesions

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dried biological amnion graft
Foley balloon
estradiol valerate tablets+dydrogesterone Tablets
Sponsored by
Beijing Obstetrics and Gynecology Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesions focused on measuring amnion graft, New biological barrier system

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age 20-40 years；
  • previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
  • complains of menstruation disorder and reproductive dysfunction；
  • informed consent.

Exclusion Criteria:

  • premature menopause,
  • presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
  • presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
  • adhesions limited to the lower uterine cavity or the cervical canal.

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

dried biological amnion graft

Foley catheter balloon only

Arm Description

patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Outcomes

Primary Outcome Measures

second diagnostic hysteroscopy

Secondary Outcome Measures

Full Information

First Posted
July 6, 2015
Last Updated
July 15, 2015
Sponsor
Beijing Obstetrics and Gynecology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02496052
Brief Title
The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions
Official Title
The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Obstetrics and Gynecology Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
Detailed Description
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesions
Keywords
amnion graft, New biological barrier system

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dried biological amnion graft
Arm Type
Experimental
Arm Description
patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Arm Title
Foley catheter balloon only
Arm Type
Sham Comparator
Arm Description
patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Intervention Type
Procedure
Intervention Name(s)
dried biological amnion graft
Other Intervention Name(s)
Uterine application of amnion membrane
Intervention Description
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
Intervention Type
Device
Intervention Name(s)
Foley balloon
Other Intervention Name(s)
Device: Foley balloon Uterine application of Foley balloon
Intervention Description
Device: Foley balloon Uterine application of Foley balloon
Intervention Type
Drug
Intervention Name(s)
estradiol valerate tablets+dydrogesterone Tablets
Other Intervention Name(s)
Progynova+dydrogesterone
Intervention Description
oral estradiol valerate tablets+dydrogesterone Tablets
Primary Outcome Measure Information:
Title
second diagnostic hysteroscopy
Time Frame
postoperation three to four months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 20-40 years； previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA； complains of menstruation disorder and reproductive dysfunction； informed consent. Exclusion Criteria: premature menopause, presence of other intrauterine lesions (e.g. polyps, myoma, septa), and presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases), adhesions limited to the lower uterine cavity or the cervical canal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Xin, MD
Phone
13681401510
Email
wx_0327@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gan Lu, MD
Phone
13552320665
Email
gl19880508@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duan Hua, Ph.D
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital，Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Zhen, M.D
Phone
+8613718210767
Email
fcyykyb@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17100817
Citation
Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x.
Results Reference
result
PubMed Identifier
28170094
Citation
Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1.
Results Reference
derived

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The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

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